UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018131 |
|---|---|
| Receipt number | R000020979 |
| Scientific Title | Prospective study of efficacy and safety of Radiotherapy in combination with KORTUC for Breast Cancer. |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2015/06/30 17:07:17 |
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Basic information
Public title
Prospective study of efficacy and safety of Radiotherapy in combination with KORTUC for Breast Cancer.
Acronym
Prospective study of efficacy and safety of Radiotherapy in combination with KORTUC for Breast Cancer.
Scientific Title
Prospective study of efficacy and safety of Radiotherapy in combination with KORTUC for Breast Cancer.
Scientific Title:Acronym
Prospective study of efficacy and safety of Radiotherapy in combination with KORTUC for Breast Cancer.
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and therapeutic effect of radiotherapy in combination with KORTUCII for stage I - IIIA breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
local control rate
Key secondary outcomes
Progression free survival (PFS), Overall survival (OS), safty profile
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Radiotherapy in combination with KORTUCII
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)pathologically proven breast cancer
2)stage I-IIIA
3)received an explanation from the specialist about the advantages and disadvantages of surgery
4)Not suitable for surgery or refused surgery
5) Suitable for radiotherapy
6) Suitable for injecting the KORTUC to the tumor
7)PS is 0-2
8)Written informed consent
Key exclusion criteria
1)prior history of radiation therapy in the thoracic.
2)Severe complication
3)History of hypersensitivity to hyaluronic acid
4)History of hypersensitivity to lidocaine hydrochloride
5)History of hypersensitivity to H2O2
6)investigator judged ineligible
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Nishimura |
Organization
Kobe Minimally Invasive Cancer Center
Division name
Department of Radiation Oncology
Zip code
Address
8-5-1 Minatojima-nakamachi, Chuo-ku, Kobe 650-0046, Japan
TEL
+81-78-304-0046
nishimura@k-mcc.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Nishimura |
Organization
Kobe Minimally Invasive Cancer Center
Division name
Department of Radiation Oncology
Zip code
Address
-5-1 Minatojima-nakamachi, Chuo-ku, Kobe 650-0046, Japan
TEL
+81-78-304-0046
Homepage URL
nishimura@k-mcc.net
Sponsor or person
Institute
Kobe Minimally Invasive Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Kobe Minimally Invasive Cancer Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 30 | Day |
Last modified on
| 2015 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020979
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
